Drug Tariff application for device reimbursement

Drug Tariff application for device reimbursement

Our client has a CE-marked Class 1 medical device which it sells in a range of European countries including the UK. The product is mainly used in the primary care setting opening the possibility for it to be reimbursed under the Drug Tariff. An application was made for reimbursement under a new product category since there was no existing suitable category. This was not accepted by the Drug Tariff, who had concerns regarding its cost-effectiveness. Cost-effectiveness data was requested, ideally in the form of robust clinical data, on the use of the product to demonstrate value for money for the NHS. It was clear that our client could perform a statistically powered clinical trial to demonstrate the cost-effectiveness of the product (or otherwise) in the primary care setting. However, such a trial would be time-consuming and costly to perform. Our consultant laid out an alternative approach which involved leveraging currently available data to assemble a package of information that achieved the same end as a purposely designed clinical trial. This involved drawing on data from previous clinical trials, using existing published data, using available case studies, and gathering testimonials from key opinion leaders.

We are a specialist medical device consultancy consisting of industry experts with long and successful track records in commercialising medical device products. We have broad functional and sector experience, and would welcome an opportunity to discuss with you any challenge relating to creating sustainable value from medical technologies.